DCT

3:25-cv-12574

Takeda Pharma USA Inc v. Lupin Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-12574, D.N.J., 07/01/2025
  • Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey based on Lupin Pharmaceuticals, Inc.'s regular and established places of business in the state, and both defendants' systematic contacts, prior consent to jurisdiction in the district, and the likelihood that the accused generic product will be sold in New Jersey.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiffs' EOHILIA® product infringes two patents related to stable corticosteroid compositions.
  • Technical Context: The technology concerns pharmaceutical formulations designed to improve the shelf-life of corticosteroids like budesonide by preventing oxidative degradation.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by Lupin's submission of ANDA No. 220382 and its Paragraph IV Certification alleging that the patents-in-suit are invalid and/or not infringed. The complaint was filed within the 45-day window following receipt of Lupin's notice letter, triggering a statutory 30-month stay of FDA approval for Lupin's ANDA.

Case Timeline

Date Event
2018-01-11 Priority Date for ’064 and ’934 Patents
2022-03-01 U.S. Patent No. 11,260,064 Issued
2023-01-31 U.S. Patent No. 11,564,934 Issued
2025-05-19 Lupin provides Paragraph IV Notice Letter to Plaintiffs
2025-07-01 Complaint for Patent Infringement Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 11,260,064 - "Stable Corticosteroid Compositions," Issued March 1, 2022

The Invention Explained

  • Problem Addressed: The patent's background section describes the problem of oxidative degradation in pharmaceuticals, specifically noting that corticosteroids like budesonide are known to degrade in the presence of oxygen, forming undesirable impurities such as 21-dehydro budesonide (21-DHB) during storage (Compl. Ex. A, '064 Patent, col. 2:12-18).
  • The Patented Solution: The invention claims to solve this problem by formulating the corticosteroid with a specific antioxidant system—a combination of ascorbic acid and a pharmaceutically acceptable salt of ascorbate—at a defined concentration. This combination is asserted to protect the corticosteroid from degradation, thereby increasing the formulation's stability and shelf-life while remaining palatable and non-allergenic ('064 Patent, col. 2:56-65; col. 8:1-5). The patent presents data in a graph showing that increasing concentrations of the ascorbate combination significantly reduce the formation of the 21-DHB impurity over several months under accelerated storage conditions ('064 Patent, FIG. 1).
  • Technical Importance: Developing stable oral liquid formulations of corticosteroids is important for treating conditions like eosinophilic esophagitis (EoE), particularly in pediatric patients who may have difficulty with other delivery methods ('064 Patent, col. 2:1-6).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶42).
  • Essential elements of independent claim 1 include:
    • A pharmaceutical composition comprising budesonide
    • An antioxidant in an amount of from about 0.05% to about 0.5% w/w of the composition
    • The antioxidant comprises a combination of ascorbic acid and a pharmaceutically acceptable salt of ascorbate
    • The composition further comprises a flavoring agent, a sweetener, or a combination thereof
    • The composition comprises less than 0.3% impurities formed by oxidative degradation
    • The composition is for oral administration
  • The complaint does not explicitly reserve the right to assert dependent claims but refers to "one or more claims" (Compl. ¶41).

U.S. Patent No. 11,564,934 - "Stable Corticosteroid Compositions," Issued January 31, 2023

The Invention Explained

  • Problem Addressed: The '934 patent, a divisional of the application that led to the '064 patent, addresses the same technical problem: the oxidative degradation of corticosteroids like budesonide in pharmaceutical formulations ('934 Patent, col. 2:15-20).
  • The Patented Solution: The '934 patent claims a method of using the stable formulation described in the parent patent. The invention is a method for treating or alleviating symptoms of eosinophilic esophagitis by administering the specific, stabilized budesonide composition to a patient ('934 Patent, Abstract; col. 8:36-49). The stability provided by the antioxidant system is central to ensuring an effective and safe dose is delivered over the course of treatment.
  • Technical Importance: This patent extends protection from the composition itself to its specific therapeutic use, a common strategy in pharmaceutical patenting to cover both the product and its FDA-approved indication ('934 Patent, col. 12:56-63).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶55).
  • Essential elements of independent claim 1 include:
    • A method of treating, or alleviating the symptoms of and inflammation associated with eosinophilic esophagitis in a subject in need thereof
    • The method comprises administering to the subject a pharmaceutical composition comprising budesonide
    • The composition includes an antioxidant in an amount of from about 0.05% to about 0.5% w/w
    • The antioxidant comprises a combination of ascorbic acid and a pharmaceutically acceptable salt of ascorbate
    • The pharmaceutical composition comprises less than 0.3% impurities formed by oxidative degradation
  • The complaint does not explicitly reserve the right to assert dependent claims but refers to "one or more claims" (Compl. ¶54).

III. The Accused Instrumentality

Product Identification

  • Lupin's proposed generic budesonide oral suspension, 2 mg/10 mL, as described in ANDA No. 220382 (the "ANDA Product") (Compl. ¶31).

Functionality and Market Context

  • The complaint alleges that Lupin's ANDA Product is a generic version of Plaintiffs' EOHILIA® drug product (Compl. ¶35). EOHILIA® is a corticosteroid indicated for the 12-week treatment of eosinophilic esophagitis (EoE) in patients 11 years of age and older (Compl. ¶9).
  • As an ANDA product, Lupin's formulation must be bioequivalent to the reference listed drug, EOHILIA®. The complaint alleges that upon approval, Lupin will market its ANDA Product for the same indication, thereby practicing the method claimed in the '934 patent (Compl. ¶54, ¶57). The complaint references FIG. 1 from the patent, which graphically demonstrates the reduction in impurity formation, a key technical benefit that the ANDA product would need to possess to be equivalent (Compl. Ex. A, '064 Patent, p. 2).

IV. Analysis of Infringement Allegations

'064 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition comprising budesonide... Lupin's ANDA Product is a budesonide oral suspension. ¶31 col. 1:14-16
an antioxidant in an amount of from about 0.05% to about 0.5% w/w of the composition, wherein the antioxidant comprises a combination of ascorbic acid and a pharmaceutically acceptable salt of ascorbate... The complaint alleges Lupin's ANDA Product contains the claimed antioxidant system within the claimed concentration range to achieve the required stability for a generic equivalent. ¶43 col. 2:58-65
and a flavoring agent, a sweetener, or a combination thereof... As a generic equivalent to a palatable oral suspension, the ANDA product is alleged to contain such agents. ¶43 col. 3:1-3
wherein the pharmaceutical composition comprises less than 0.3% impurities formed by oxidative degradation... The complaint alleges that to be a viable generic equivalent, Lupin's ANDA Product must meet this stability requirement. ¶43 col. 2:48-56
and wherein the pharmaceutical composition is for oral administration. Lupin's ANDA seeks approval for a "budesonide suspension for oral use." ¶31 col. 3:12-13

'934 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating, or alleviating the symptoms of and inflammation associated with eosinophilic esophagitis in a subject in need thereof... The complaint alleges Lupin's product labeling will instruct for its use to treat eosinophilic esophagitis, the approved indication for EOHILIA®. ¶57 col. 3:27-34
comprising administering to the subject a pharmaceutical composition comprising budesonide, and an antioxidant in an amount of from about 0.05% to about 0.5% w/w... wherein the antioxidant comprises a combination of ascorbic acid and a pharmaceutically acceptable salt of ascorbate... The administration involves the use of Lupin's ANDA Product, which is alleged to have the claimed composition. ¶56 col. 2:58-65
wherein the pharmaceutical composition comprises less than 0.3% impurities formed by oxidative degradation. The method requires administering a composition that meets this stability profile, which the ANDA product is alleged to possess. ¶56 col. 2:48-56

Identified Points of Contention

  • Technical Questions: A primary factual question will be whether Lupin's ANDA Product formulation, as detailed in its confidential ANDA submission, actually falls within the scope of the claims. Specifically, does it use the claimed antioxidant combination at the claimed concentration, and does it achieve the claimed impurity level of "less than 0.3%"?
  • Scope Questions: The interpretation of "a combination of ascorbic acid and a pharmaceutically acceptable salt of ascorbate" may be contested. For example, the parties could dispute whether any ratio of the two components is covered, or if the specification supports a more limited range of ratios necessary to achieve the claimed stability.

V. Key Claim Terms for Construction

  • The Term: "comprises less than 0.3% impurities formed by oxidative degradation" ('064 Patent, Claim 1; '934 Patent, Claim 1)
  • Context and Importance: This negative limitation is the central feature defining the stability of the invention. Proving infringement will require showing that the accused product meets this purity threshold. Practitioners may focus on this term because its definition (e.g., how and when the impurity level is measured, and which specific impurities count) will be dispositive.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself does not specify the storage conditions or time under which the <0.3% impurity level must be met, which could support an interpretation that the limitation must be met upon release of the product.
    • Evidence for a Narrower Interpretation: The specification provides data for impurity levels "after one month of storage, or after two months of storage," etc., under accelerated conditions (40°C/75% RH) ('064 Patent, col. 2:50-56; FIG. 1). A defendant may argue that the claim should be read in light of these examples, requiring the stability to be maintained over time, not just at manufacture. The specific mention of "21-dehydrobudesonide (21-DHB)" as the "undesirable" species could also be used to argue the claim is focused on this particular impurity ('064 Patent, col. 2:16-18).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement of the '934 method patent, asserting that Lupin's FDA-approved labeling will inevitably instruct physicians and patients to administer the ANDA Product to treat eosinophilic esophagitis, thereby encouraging infringement (Compl. ¶57-58). It also alleges contributory infringement, stating the ANDA product is especially adapted for this infringing use and has no substantial non-infringing use (Compl. ¶59).
  • Willful Infringement: The complaint does not use the word "willful" but requests a finding that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶62). The basis for this is Lupin's alleged knowledge of the patents "since at least the date of Lupin's ANDA submission" (Compl. ¶48, ¶60).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of evidentiary proof: can Plaintiffs demonstrate, through discovery of Lupin's confidential ANDA, that the accused generic product's formulation and stability profile literally meet every limitation of the asserted claims, particularly the negative limitation requiring "less than 0.3% impurities"?
  • A key legal question will be one of claim scope: how will the court construe the phrase "a combination of ascorbic acid and a pharmaceutically acceptable salt of ascorbate"? The outcome may depend on whether the specification is found to limit the term to specific ratios or concentrations necessary to achieve the stability shown in the patent's own examples.
  • A central question for the '934 method patent will be inducement: assuming the ANDA product is found to be the composition of the '064 patent, will Lupin's proposed product label be found to contain sufficient instruction to actively encourage medical professionals and patients to perform the patented method of treatment, thereby establishing the requisite intent for inducement?